# US 12,594,096 B2 · Systems and methods for enhanced implantation of electrode leads between tissue layers > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,096 B2 - Document ID: US12594096B2 - Status: Granted - Kind: B2 - Application number: 18/614,512 - Filed: 2024-03-22 - Published: 2024-10-17 - Granted: 2026-04-07 - Earliest claimed: 2012-06-13 - Assignees: Mainstay Medical Limited - Applicants: Mainstay Medical Limited - Inventors: Jason Alan Shiroff; Henry Demorett; John Beck; Sidney Hauschild - Web page: https://patentgrep.com/patent/US12594096B2 ## CPC - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B 18/00: Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body (eye surgery A61F9/007; ear surgery A61F11/00) - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/0558: {Anchoring or fixation means therefor} - A61B 2018/00339: {Spine, e.g. intervertebral disc} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract Systems and methods for enhanced implantation of an electrode lead for neuromuscular electrical stimulation of tissue associated with control of the lumbar spine for treatment of back pain, in a midline-to-lateral manner are provided. The implanted lead may be secured within the patient and used to restore muscle function of local segmental muscles associated with the lumbar spine stabilization system without disruption of the electrode lead post-implantation due to anatomical structures. ## Claims ### Claim 1 A method for implanting a tined lead for restoring muscle function to a lumbar spine of a patient, the method comprising: selecting an elongated tubular element having a longitudinal axis and a distal tip; selecting a lead having a longitudinal axis, a proximal region, a distal region opposite said proximal region including one or more electrodes, and at least two tines angled relative to said longitudinal axis of said lead away from said distal region and towards said proximal region, wherein the at least two tines comprise a pair of oppositely-angled fixation tines disposed in proximity to at least one of the one or more electrodes, the pair of oppositely-angled fixation tines configured to transition from a collapsed delivery state to a deployed state; inserting said distal tip of said elongated tubular element percutaneously towards a target vertebral site adjacent to a medial branch of the dorsal ramus of the lumbar spine of the patient; inserting the lead through said elongated tubular element such that the distal region of said lead is positioned adjacent to said medial branch of the dorsal ramus of the lumbar spine of the patient; and retracting the elongated tubular element while maintaining the lead in a generally stationary position relative to the target site to cause the pair of oppositely-angled fixation tines to transition from the collapsed delivery state to the deployed state to anchor said lead at an intertransversarii such that the pair of oppositely-angled fixation tines sandwich the intertransversarii in the deployed state so said one or more electrodes are positioned near the medial branch of the dorsal ramus of the lumbar spine of the patient. ### Claim 2 (depends on 1) The method of claim 1, wherein the target vertebral site is an L3 vertebra. ### Claim 3 (depends on 1) The method of claim 1, further comprising percutaneously inserting a guide needle at an insertion site located a lateral distance from a midline of the target vertebral site and proximately lateral to a base of a superior articular process of the target vertebral site. ### Claim 4 (depends on 1) The method of claim 1, further comprising visualizing the distal tip of the elongate tubular element within an outline of a neural foramen of the target vertebrae to confirm target positioning of the elongate tubular element. ### Claim 5 (depends on 4) The method of claim 4, wherein visualizing the distal tip of the elongate tubular element comprises visualizing the distal tip of the elongate tubular element via at least one of x-ray, fluoroscopy, acoustic, anatomic, or CT guidance. ### Claim 6 (depends on 4) The method of claim 4, wherein visualizing the distal tip of the elongate tubular element comprises visualizing the distal tip of the elongate tubular element via at least one of lateral, anterior, or posterior images. ### Claim 7 (depends on 1) The method of claim 1, wherein the elongate tubular element is a guide needle or an introducer. ### Claim 8 (depends on 1) The method of claim 1, further comprising: measuring a depth attained by a guide needle at a first insertion site; and locating a second insertion site along a midline of the target vertebral site based on the depth. ### Claim 9 (depends on 8) The method of claim 8, wherein the second insertion site is located a distance from the first insertion site approximately equal to the depth. ### Claim 10 (depends on 1) The method of claim 1, wherein the one or more electrodes are disposed near or in contact with a dorsal ramus nerve or fascicles thereof. ### Claim 11 (depends on 1) The method of claim 1, wherein the at least two tines are approximately angled 45 degrees relative to the longitudinal axis of the lead. ### Claim 12 (depends on 1) The method of claim 1, wherein inserting the distal tip of the elongate tubular element further comprises advancing the distal tip of the elongate tubular element to penetrate the intertransversarii associated with the target vertebral site. ### Claim 13 (depends on 1) The method of claim 1, wherein inserting the distal tip of the elongate tubular element comprises advancing the distal tip of the elongate tubular element until the distal tip is located within a plane of the intertransversarii. ### Claim 14 (depends on 1) The method of claim 1, further comprising: inserting a stylet through a lumen of the lead prior to advancing the lead through the elongated tubular element; and removing the stylet from the lead when the one or more electrodes are disposed near or in contact with tissue associated with the medial branch of the dorsal ramus of the lumbar spine. ### Claim 15 (depends on 1) The method of claim 1, further comprising implanting an implantable pulse generator configured to be coupled to the lead. ### Claim 16 (depends on 1) The method of claim 1, further comprising causing the one or more electrodes to stimulate the tissue associated with control of the lumbar spine. ### Claim 17 (depends on 1) The method of claim 1, wherein implanting the lead comprises implanting the lead such that the one or more electrodes are positioned to stimulate nervous tissue innervating a multifidus muscle.